XLUNG KIT 230
Received Mar 11, 2026 · Event occurred Feb 13, 2026
Report 3012172416-2026-00019 · MDR key 24567534
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
GSXG1403
Product problems
- Material Deformation
- Material Integrity Problem
- Insufficient Device Problem Information
Patient
68 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D4, D9, H3 PLANT INVESTIGATION: NONCONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. NO OTHER SIMILAR COMPLAINTS HAVE BEEN REPORTED ABOUT THIS BATCH NUMBER. THE SAMPLE WAS RETURNED FOR EVALUATION ON (B)(6) 2026. THE BASE OF THE INNER HOUSING OF THE PUMP HEAD WAS NOT FLAT (AS INTENDED) BUT CURVED SLIGHTLY UPWARDS. THE PUMP HEAD THEREFORE WAS NOT FITTING PROPERLY ONTO THE PUMP DRIVE. THE CLAMPS ON THE PUMP DRIVE COULD NOT BE CLOSED OVER THE PUMP HEAD HOUSING. THE ISSUE IS CAUSED BY AN ERROR DURING THE INJECTION MOLDING OF THE INNER HOUSING OF THE PUMP HEAD. THE FAILURE PATTERN IS A KNOWN ISSUE THAT IS DUE TO THE AGE OF THE MOLD AND THE HOT RUNNER SYSTEM. THE CREATION OF A NEW INJECTION MOLD WAS CREATED TO ADDRESS THE ISSUE.
Description of Event or Problem
A USER FACILITY REPORTED THAT THE PUMP HEAD OF THE XLUNG KIT 230 COULD NOT BE FASTENED SECURELY TO THE PUMP DRIVE. UNFORTUNATELY, THE KIT WAS USED ANYWAYS AND WAS SWITCHED SHORTLY AFTER THE START OF SUPPORT. THE USER BELIEVED THE PUMP HEAD WAS THE ISSUE AND NOT THE PUMP DRIVE BUT COULD NOT CONFIRM. UPON FOLLOW-UP, IT WAS REPORTED THAT THE PATIENT WAS ABLE TO CONTINUE SUPPORT WITHOUT INCIDENT FOLLOWING KIT EXCHANGE. THERE WAS NO PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS RECEIVED BY THE MANUFACTURER FOR PRODUCT INVESTIGATION.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
Description of Event or Problem
A USER FACILITY REPORTED THAT THE PUMP HEAD OF THE XLUNG KIT 230 COULD NOT BE FASTENED SECURELY TO THE PUMP DRIVE. UNFORTUNATELY, THE KIT WAS USED ANYWAYS AND WAS SWITCHED SHORTLY AFTER THE START OF SUPPORT. THE USER BELIEVED THE PUMP HEAD WAS THE ISSUE AND NOT THE PUMP DRIVE BUT COULD NOT CONFIRM. THERE WAS NO PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.
Description of Event or Problem
A USER FACILITY REPORTED THAT THE PUMP HEAD OF THE XLUNG KIT 230 COULD NOT BE FASTENED SECURELY TO THE PUMP DRIVE. UNFORTUNATELY, THE KIT WAS USED ANYWAYS AND WAS SWITCHED SHORTLY AFTER THE START OF SUPPORT. THE USER BELIEVED THE PUMP HEAD WAS THE ISSUE AND NOT THE PUMP DRIVE BUT COULD NOT CONFIRM. UPON FOLLOW-UP, IT WAS REPORTED THAT THE PATIENT WAS ABLE TO CONTINUE SUPPORT WITHOUT INCIDENT FOLLOWING KIT EXCHANGE. THERE WAS NO PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: SECTION A (PATIENT INFORMATION), B5 THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.